Pneumoperitoneum device

ABSTRACT

A method for performing a laparoscopic procedure may include inserting a bag through an opening. The method may also include delivering tissue into the bag, sealing the bag, and inflating the bag to create an artificial pneumoperitoneum that extends the abdomen and provides additional working and viewing space. Further, the method may include carrying out a procedure on the tissue located in the inflated bag.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-in-Part of U.S. application Ser. No.13/725,148, filed Dec. 21, 2012, and claims the benefit of U.S.Provisional Patent Application No. 61/580,088 filed on Dec. 23, 2011,and 61/742,125 filed on Aug. 3, 2012, the entire contents of all ofwhich are incorporated herein by reference. Additionally, thisapplication claims the benefit of U.S. Provisional Patent ApplicationNos. 61/839,461, filed on Jun. 26, 2013, 61/940,681 filed on Feb. 17,2014, and 61/968,770, filed on Mar. 21, 2014, the entire contents of allof which are incorporated herein by reference.

INTRODUCTION

This invention relates to a pneumoperitoneum device. The invention alsorelates to a method of performing a surgical procedure.

STATEMENTS OF INVENTION

According to the invention there is provided an artificialpneumoperitoneum device (e.g., a bag) for receiving tissue, tissueisolation, and/or extraction in a laparoscopic procedure.

In one aspect the invention provides an apparatus for use in duringlaparoscopic surgery comprising an inflatable bag having atissue-receiving opening at a proximal end thereof and a cuff at theproximal opening, the cuff having a closed configuration for deliveryand retrieval of the bag and an open configuration to receive tissue,the cuff being biased into the open configuration.

In one embodiment the bag has a main body which extends from the cuffand the main body of the bag is more flexible than the cuff. The cuffmay be of a different material than that of the main body of the bag.The cuff may be of a stiffer material than that of the main body of thebag.

In some embodiments the cuff extends for a distance of between 2 and 20cm, between 2 and 10 cm, or about 5 cm.

In one embodiment the bag comprises a biasing element (e.g., a ring)that extends at least partially around the opening. The biasing element(e.g., ring) is preferably flexible to facilitate entry through anincision and/or an instrument access port. That is, the biasing element(e.g., ring) may bias the cuff into the open configuration.

In one case the biasing element (e.g., ring) comprises a loop (e.g., anO-ring) extending around the cuff. The loop may be of a shape memorymaterial such as Nitinol. The loop may comprise a single loop elementwhich is open or closed.

In one case the loop comprises a plurality of loop parts.

In some embodiments at least one of the loop parts is movable relativeto another of the loop parts. At least one of the loop parts may bemovable circumferentially relative to another ring element.

In one case the apparatus comprises a retainer for opening the bag.

The retainer may comprise at least one ring element which extends atleast partially around the opening. The ring element may be flexible tofacilitate entry through an incision and/or an instrument access port.In one case the ring element comprises an O-ring.

In one embodiment the retainer comprises ring parts.

There may be two separate ring parts.

In one embodiment the apparatus (e.g., bag) comprises a tether for eachof the ring parts.

In some embodiments, the bag may comprise a tether extending proximallyfrom the cuff. The cuff may comprise a tab for use in grasping the bag.

In one aspect the retainer has an insertion configuration and anexpanded deployed configuration. The retainer may be biased into thedeployed configuration.

In one case the bag is foldable for insertion.

The invention also provides an apparatus comprising an introducer sheathor pouch for containing the bag in an insertion configuration. Theintroducer sheath or pouch may be at least partially insertable throughan opening and/or an incision and/or an access port.

In one case the apparatus comprises an activator for delivering the bagfrom the pouch, on insertion. The activator may comprise a tab. In onecase the activator comprises a plunger.

In one embodiment the apparatus comprises a user tether attached to thebag.

In one case the bag comprises a neck region. The neck region may beadjacent to the retainer.

In one embodiment the bag itself comprises a port. The port may be anexit port and/or an entrance port. The bag may comprise a plurality ofports.

In some embodiments the port comprises a valve. The valve may comprise achoke valve or a cuff valve. In one case the valve comprises anelastomeric material such as a gel.

In some embodiments the apparatus comprises a proximal tether and adistal tether.

The distal tether may be movable relative to the proximal tether.

In one case the proximal tether comprises a loop through which thedistal tether is movable.

There may be a lock to restrict movement of the distal tether. In onecase the lock is provided by or on the proximal and/or the distaltether. The lock may comprises a projection on the distal tether whichis engagable by the proximal tether.

In one embodiment the apparatus further comprises an access port towhich the bag is mounted or mountable. The access port may comprise aretractor having a distal anchoring element for location within a woundinterior, a proximal member for location externally of a wound openingand a retractor member extending proximally from the distal anchoringelement to retract laterally the sides of an incision.

The bag may be mountable to the proximal member of the retractor.

In one embodiment the apparatus further comprises a cap for closing theproximal side of the retractor. The cap may comprise an access devicefor an instrument or a surgeons hand/arm. The access device may bemountable to the proximal member of the retractor.

The invention also provides apparatus for use in laparoscopic surgerycomprising a bag of the invention and a retractor. The apparatus mayfurther comprise an access port.

The invention also provides a visceral retainer comprising an apparatusof the invention.

In another aspect the invention provides a method for performing alaparoscopic procedure comprising the steps of:

-   -   inserting a bag according to the invention through an opening;    -   inflating the bag;    -   delivering tissue into the bag before or after inflating the        bag; and    -   carrying out a procedure on the tissue located in the inflated        bag.

In one embodiment the opening is an opening into a body cavity.

The opening may be provided, at least in part, by an incision.

In one embodiment the method comprises providing a trocar and insertingthe bag through the trocar.

The method may comprise providing a retractor in the opening andinserting the bag through the retracted opening.

The tissue may be delivered into the bag before inflating the bag.

The method may comprise the step, either before or after delivery of thetissue into the bag, of mounting the bag to the retractor.

In one embodiment the method comprises passing an instrument into theinflated bag to carry out a procedure.

In one case the method comprises inserting a trocar into the bag.

The method may comprise the steps of providing an access port in the bagand passing an instrument and/or tissue through the access port.

In one embodiment the method comprises sealing the access port prior toand/or subsequent to passage of an instrument and/or tissue through theaccess port.

The device of the invention comprises at least one instrument seal toeffect a seal around at least one instrument extended through thedevice, the instrument seal being configured to be arranged in sealingrelationship to a body of a patient. The device preferably has a distalanchoring member for location within a wound interior. The devicepreferably also has a retractor member extending proximally from thedistal anchoring member to retract laterally the sides of a woundopening. Preferably the device comprises a first instrument seal toeffect a seal around a first instrument extended through the device, anda second instrument seal to effect a seal around a second instrumentextended through the device. By providing the two seal arrangement, thisensures that insertion or manipulation or removal of the secondinstrument does not adversely effect the seal around the firstinstrument. The device may comprise a third instrument seal to effect aseal around a third instrument extended through the device. The firstinstrument seal may be spaced apart from the second instrument seal. Thefirst instrument seal may be formed separately from the secondinstrument seal. The first instrument seal may have a larger radialdimension than the second instrument seal. The instrument seal may be avalve. Alternatively, the seal is of a gelatinous elastomeric material.

In one case the device comprises a proximal member for locationexternally of a wound opening. The retractor member may extend at leastbetween the distal anchoring member and the proximal member. Theretractor member may extend in two layers between the distal anchoringmember and the proximal member. A first end portion of the retractormember may be fixed to the proximal member. The retractor member may bemovable relative to the distal anchoring member. A second end portion ofthe retractor member may be movable relative to the proximal member. Theretractor member may extend distally from the proximal member to thedistal anchoring member, may be looped around the distal anchoringmember, and may extend proximally from the distal anchoring member tothe proximal member. The proximal member may comprise an inner part andan outer part. The retractor member may extend between the inner partand the outer part.

In another embodiment the instrument seal is spaced proximally of theproximal member. The device may comprise at least one connector memberto connect the proximal member to the at least one instrument seal. Theconnector member facilitates a degree of lateral movement of theinstrument while maintaining the seal. The connector member may comprisea sleeve. The connector member may be of a laterally flexible material.The connector member may be of a longitudinally rigid material. Theconnector member may be of a rubber-like material. The connector membermay be of a longitudinally flexible material.

In another case the instrument seal is mounted to the connector member.The instrument seal may be releasably mounted to the connector member.The instrument seal may comprise a mounting part to mount the instrumentseal to the connector member. The mounting part may be of a rigidmaterial. The instrument seal may comprise a sealing part to effect aseal around an instrument extended through the device, the sealing partbeing overmolded over at least part of the mounting part.

In one embodiment, a method for performing a laparoscopic procedure mayinclude inserting a bag through a patient opening, delivering tissueinto a bag opening of the bag, withdrawing the bag opening back throughthe patient opening, sealing the bag, inflating the bag to create anartificial pneumoperitoneum that extends the abdomen, conforms to theperitoneal cavity, and provides additional working and viewing space;and carrying out a procedure on the tissue located in the inflated bag.

In another embodiment, a method for performing a laparoscopic procedureincludes inserting a bag through a patient opening and into a peritonealcavity, delivering tissue into the bag in an insufflated peritonealcavity, sealing the bag, inflating the bag to apply a retracting forceto the materials outside the bag thereby enlarging the peritonealcavity, carrying out a procedure on the tissue located in the inflatedbag; and allowing the peritoneal cavity to uninsufflate so that theinflated bag is located in an uninsufflated peritoneal cavity.

In yet another embodiment, a method for performing a laparoscopicprocedure includes inserting a bag through a patient opening and into aperitoneal cavity, delivering tissue into the bag, sealing the bag,inflating the bag to retract surrounding structures and organs and urgethe bag against the abdominal wall, piercing the bag by one or moretrocars at a location where the bag is urged against the abdominal wall,carrying out a procedure on the tissue located in the inflated bag, andcommunicating the peritoneal cavity with the atmosphere prior tocarrying out a procedure on the tissue located in the inflated bag.

In a further embodiment, a method for performing a laparoscopicprocedure includes insufflating the peritoneal cavity to provide aworking and viewing space, excising tissue within the working andviewing space, inserting a bag into the working and viewing space,delivering the excised tissue into the bag, sealing the bag, inflatingthe bag to replace the working and viewing space of the insufflatedperitoneal cavity with a working and viewing space within the bag, andcarrying out a procedure on the tissue located in the inflated bag.

The methods for performing a laparascopic procedure may further includeone or more of the following features: the opening may be a nakedincision in the abdominal wall; the opening may be one of an openingthrough a retractor device coupled to an incision, or an opening througha trocar coupled to an incision; the inserting of a bag through anopening may include inserting the bag through a valve; the extending ofthe abdomen includes the bag contacting both the anterior abdominal walland the abdominal visecera; the opening may be an opening through theretractor device, and the sealing of the bag may include sealing the bagto a proximal end of the retractor device with a cap; the delivering oftissue into the bag may be performed in an insufflated peritonealcavity; the carrying out of a procedure in the inflated bag may beperformed in an uninsufflated peritoneal cavity; the inflating of thebag may include inflating the bag to retract surrounding structures andorgans and urge the bag against the abdominal wall; piercing the bagwith one or more trocars at a location where the bag may be urgedagainst the abdominal wall; the carrying out of a procedure may includesealably inserting a morcellator into the bag and morcellating thetissue; and retrieving the tissue by pulling the bag out through theopening.

In yet another embodiment, an inflatable artificial pneumoperitoneum bagincludes a length and a width, an artificial pneumoperitoneum bag neckportion having a first end and a second end, the first end forming a bagopening, an artificial pneumoperitoneum bag body portion forming aclosed cavity in fluid communication with the second end of the neckportion, the body portion having a length and width greater than alength and width of the neck portion, and a ring located at the bagopening, the ring configured to bias the bag opening toward an opencondition.

In yet another embodiment, an inflatable artificial pneumoperitoneumbag, including a first planar sheet portion and a second planar sheetportion, the first and second planar sheet portions having joined edgesto form the pneumoperitoneum bag having a length and a width, a neckportion having a first end and a second end, the first end forming a bagopening, a body portion forming a closed cavity in fluid communicationwith the second end of the neck portion, the body portion having alength and width greater than a length and width of the neck portion,and a ring located at the bag opening, the ring configured to bias thebag opening toward an open condition.

The inflatable artificial pneumoperitoneum bag may further include oneor more of the following features: a length of the bag is between 300and 600 mm when the bag is uninflated, and a maximum width of the bag isbetween 200 and 500 mm when the bag is uninflated; the neck portion hasa diameter of between 100 and 220 mm when in the open condition; theneck portion has a length of between 100 and 300 mm when the bag isuninflated; a width-extending cross-section of the body portion includesan oval shape when the bag is inflated; the bag includes sterilizedpolyester polyurethane planar sheet portions having joined edges; thebag is symmetric about two planes that are normal to one another; theneck portion includes edges that extend parallel to a lengthwise axis ofthe bag; and the ring is formed of a shape memory material and isreceived through loops in the neck portion.

In another embodiment, a method includes creating an artificialpneumoperitoneum in a patient using an artificial pneumoperitoneum bag,the artificial pneumoperitoneum bag including a length and a width, aneck portion having a first end and a second end, the first end forminga bag opening, a body portion forming a closed cavity in fluidcommunication with the second end of the neck portion, the body portionhaving a length and width greater than a length and width of the neckportion, and a ring located at the bag opening, the ring configured tobias the bag opening toward an open condition.

In another embodiment, a method includes creating an artificialpneumoperitoneum in a patient using an artificial pneumoperitoneum bag,the artificial pneumoperitoneum bag including a first planar sheetportion and a second planar sheet portion, the first and second planarsheet portions having joined edges to form the pneumpoeritoneum baghaving a length and a width, a neck portion having a first end and asecond end, the first end forming a bag opening, a body portion forminga closed cavity in fluid communication with the second end of the neckportion, the body portion having a length and width greater than alength and width of the neck portion, and a ring located at the bagopening, the ring configured to bias the bag opening toward an opencondition, and the creating of the artificial pneumoperitoneum includespositioning the joined edges in alignment with the lateral walls of theabdomen.

The methods for performing a laparascopic procedure may further includeone or more of the following features: the length of the bag is between300 and 600 mm when the bag is uninflated, and a maximum width of thebag is between 200 and 500 mm when the bag is uninflated; the neckportion has a diameter of between 100 and 220 mm when in the opencondition; the neck portion has a length of between 100 and 300 mm whenthe bag is uninflated; a width-extending cross-section of the bodyportion includes an oval shape when the bag is inflated; the bag isformed of sterilized polyester polyurethane planar sheet portions havingjoined edges; the bag is symmetric about two planes that are normal toone another; the neck portion includes edges that extend parallel to alengthwise axis of the bag; the ring is formed of a shape memorymaterial and is received through loops in the neck portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdescription of some embodiments thereof, given by way of example only,with reference to the accompanying drawings, in which:

FIG. 1 is an isometric view of a pneumoperitoneum device according tothe invention;

FIG. 2 is another isometric view of the device of FIG. 1;

FIGS. 3 to 5 are views of another pneumoperitoneum device according tothe invention;

FIGS. 6 to 18 are diagrams illustrating the use of the device of FIGS. 1to 5;

FIGS. 19 to 22 are diagrams illustrating another use of the device ofFIGS. 1 to 5;

FIGS. 23 to 24 are diagrams illustrating a further use of the device ofFIGS. 1 to 5;

FIGS. 25 to 30 are diagrams illustrating various ways in which a deviceaccording to the invention may be introduced;

FIGS. 31 to 35 are diagrams illustrating the device, in use;

FIG. 36 is a diagram of another device according to the invention;

FIGS. 37 to 45 are diagrams illustrating the device of FIG. 36, in use;

FIG. 46 is a diagram of another device according to the invention;

FIGS. 47 to 54 are diagrams illustrating the device of FIG. 46, in use;

FIG. 55 is a diagram of a further device according to the invention;

FIGS. 56 to 63 are diagrams illustrating the device of FIG. 55, in use;

FIG. 64 is a diagram of another device according to the invention;

FIGS. 65 to 74 are diagrams illustrating the device of FIG. 64, in use;

FIG. 75 is a diagram of a device according to the invention for use as avisceral retainer;

FIGS. 76 to 78 are diagrams illustrating the device of FIG. 75, in use;

FIG. 79 is a diagram of the device of FIGS. 75 to 78 with an associatedgrommet;

FIGS. 80 and 81 are diagrams illustrating the device of FIGS. 75 to 78in use;

FIGS. 82 to 87 are isometric views of alternative grommets;

FIG. 88 is an isometric view of another device according to theinvention with a multi-lumen access port removed;

FIG. 89 is an isometric, partially cut-away view of the device of FIG.88 with an access port in position for use;

FIG. 90 is an isometric view of a device according to the invention.

FIG. 91 is another view of the device of FIG. 90 with an access port inposition for use;

FIGS. 92( a) and 92(b) are isometric views of single lumen access portsfor use with the devices of the invention;

FIG. 93 is an isometric view of a pneumoperitoneum device according toanother embodiment of the invention with an exit port from the device;

FIG. 94 is an isometric view of another device similar to FIG. 93 with anumber of exit ports;

FIG. 95 is an isometric view illustrating devices of the types of FIGS.93 and 94, in use;

FIGS. 96 to 98 are views of various seals that may be used inassociation with the device;

FIGS. 99 to 110 illustrate one method of use of devices according to theinvention;

FIGS. 111 to 113 are views illustrating a locking detail of the deviceof FIGS. 99 to 110;

FIGS. 114 to 117 are views of a device according to the invention, inuse in the colon;

FIG. 118 is an isometric view of another device according to theinvention;

FIG. 119 is an isometric view of a further device according to theinvention;

FIG. 120 is an isometric view of a pneumoperitoneum device according tothe invention loaded in an introducer;

FIG. 121 is an isometric view of a bag according to the invention;

FIG. 122 is a cross sectional view on the line A-A in FIG. 121;

FIGS. 123 to 126 are isometric views illustrating the insertion of thebag through an opening;

FIGS. 127 and 128 are isometric views illustrating the delivery oftissue into the bag;

FIGS. 129 and 130 are isometric views illustrating the closing of thebag;

FIGS. 131 to 133 are isometric views illustrating the presentation ofthe bag to the tissue opening, subsequent inflation of the bag, andprocedures such as morcellation being carried out on tissue in theinflated bag;

FIGS. 134 to 138 are diagrams illustrating various alternativearrangements of trocar(s) and instrument(s) used in performingprocedures on tissue in the inflated bag;

FIGS. 139 to 143 are various views of a biasing loop comprising loopsections which are movable relative to one another;

FIGS. 144 to 149 are various views of another biasing loop;

FIGS. 150 to 153 are various views of a further biasing loop;

FIGS. 154 to 156 are various views of another biasing loop;

FIGS. 157 to 160 are diagrams illustrating another bag device of theinvention;

FIGS. 161 to 164 illustrate another bag device of the invention in use;

FIG. 165 is an isometric view illustrating closing of a bag device;

FIGS. 166 to 168 are isometric views of further bag devices according tothe invention with a retaining ring in place in a cuff of the bags;

FIGS. 169( a)-169(c) and 170 illustrate the mounting of a ring to thecuff of the bag of FIG. 168;

FIG. 171 shows a protector cap for a bag device;

FIGS. 172 to 176 illustrate an introducer for use in deploying andmanipulating a bag device;

FIGS. 177 to 180 are views of further introducers with various pressuredissipating features;

FIGS. 181 to 184 illustrate another bag device having a generally ovoidshape;

FIGS. 185 and 186 illustrate a retaining ring of the bag;

FIGS. 187( a) to 187(f) are views illustrating the loading of a bagdevice into an introducer;

FIG. 188 is an illustration of a bag device with a re-inforced section;

FIG. 189 shows an introducer with a valve;

FIGS. 190( a) to 190(c) illustrate the use of a bag device intransvaginal procedures;

FIG. 191 is a view of a part of a bag with a threaded bung or trocar inplace;

FIGS. 192( a) and 192(b) illustrate the closing of a chimney of a bag,prior to deflation; and

FIGS. 193( a) to 193(c) illustrate the use of the bag devices of theinvention with various access devices.

DETAILED DESCRIPTION

The invention provides an artificial pneumoperitoneum device for tissueisolation and/or extraction in a laparoscopic procedure

The device is used to safely reduce and remove resected tissue fromwithin the abdomen via small laparoscopic incisions. The bag creates anartificial pneumoperitoneum containing the specimen and eliminating thedissemination of tissue and cellular fluids within the peritonealcavity. The device facilitates effective and safe isolation oftissue/organs within an artificial pneumoperitoneum for improvedsurgical procedures and subsequent safe tissue extraction.

A tissue bag is inserted within the peritoneal cavity through anincision in the abdominal wall or vagina.

In one case the bag with one or more openings is placed within theabdomen. Excised tissue is placed within the opening of a deflated bag.One or more openings of the bag are withdrawn outside the abdomen andthe bag is inflated. Instruments including laparoscopic visualizationare placed within the inflated bag that remains within the peritonealcavity. Visualisation tools may also be provided external of the bag.The tissue retained within the bag is morcellated/crushed/reduced andremoved. The bag is deflated and removed with residualtissue/blood/fluids inside. A major advantage is that the tissue to beremoved is retained in the bag which prevents potentially harmfulmaterial such as cancerous cells from being released in the body cavity.

Referring to the drawings, and initially to FIGS. 1 and 2 thereof, thereis illustrated an apparatus for use in laparoscopic surgery comprising abag 1 having an opening 2 to receive tissue and a ring element 3extending around the opening 2. The bag is inflatable.

Referring to FIGS. 3 to 5, there is illustrated another bag deviceaccording to the invention which is similar to the bag device of FIGS. 1and 2 and like parts are assigned the same reference numerals. In thiscase the bag 1 has a necked region 5 to reduce the amount of materialnear the ring 3. This facilitates attachment of the bag 1 to an externalelement.

The bag device 1 is suitable for use during laparoscopic surgery tofacilitate procedures on tissue in an insufflated cavity whilemaintaining pneumoperitoneum.

The bag device 1 may be mounted to a retractor. One such retractorcomprises a distal anchoring ring 10, a retractor member such as asleeve 11, and a proximal ring assembly 12.

One such retractor is described in US 2005-0090717 A, the entirecontents of which are incorporated herein by reference. The distalanchoring ring 10 is located within a wound interior, in use. In thiscase the distal anchoring ring 10 is provided in the form of an O-ring.The proximal ring assembly 12 is located externally of a wound opening,in use. The retractor member 11 may be employed to retract laterally thesides of a wound opening. In this case, the retractor member is providedin the form of a sleeve.

The proximal end of the retractor 11 is closable by a cap which in thiscase comprises an instrument access device 30 which may have a number ofinstrument ports 31 to effect a seal around an instrument extendedthrough the device 30. The instrument access device 30 may be releasablymountable to the proximal ring assembly 12. At least some of theinstrument ports may include a stalk 32 which is laterally flexible andlongitudinally rigid.

FIG. 6 illustrates an instrument 51 being introduced under visionprovided by a camera 52 through an instrument access port 31.

FIG. 7 shows an organ or tissue such as an uterus 35 which has, beensevered from it's retaining structures.

FIG. 8 illustrates the bag device 1 being inserted into the abdominalcavity at the beginning of a procedure or as and when required. The bag1 is inserted in a small flattened state for ease of insertion through asmall opening such as an incision. As shown in FIG. 8, the bag device 1is inserted through an opening that is open to the atmosphere, and thusthe peritoneal cavity is uninsufflated in this embodiment. The bag mayalso be introduced through a valve without the need to remove the accesscap 30. One such arrangement is illustrated in FIG. 10, and this allowsthe bag device to be inserted into an insufflated peritoneal cavity.

When the bag 1 is inserted in the insufflated or uninsufflatedperitoneal cavity, it is opened up (FIG. 9). An organ is then readilymanipulated for insertion into the bag 1 as illustrated in FIG. 11. Therigidity of the O-ring 3 keeps the bag open to facilitate insertion ofan organ.

FIG. 12 shows the organ located in the bag 1 and the O-ring 3 beinggrasped to facilitate manipulation of the bag towards the opening. Asshown in FIG. 12, removal of access cap 30 provides an uninsufflatedperitoneal cavity prior to inflating the bag device 1. The uninsufflatednature of the peritoneal cavity helps the bag device 1 expand as shownin FIG. 16, and apply a retracting force to the materials outside thebag thereby creating additional space (FIG. 76). It is understood thatthe bag device 1 could be inflated while the peritoneal cavity isinsufflated if there is one or more openings to the peritoneal cavitythat allow the insufflation gas to escape to the cavity. One suchopening could be provided through an open trocar device or trocarincision opening that was used to carry out the tissue excisingexplained above. The O-ring 3 is pulled out through the opening (FIG.13) and the bag 1 is mounted to the proximal ring assembly 12 and thecap 30 is mounted to the proximal assembly 12 (FIG. 14). FIG. 15illustrates the device in place with an organ enclosed within the bag 1.

The bag 1 is then inflated through an insufflation port 40. Theinflation of the bag has the additional benefit of applying a retractingforce to the materials outside the bag 1 thereby creating additionalspace (FIG. 16). Thus, the artificial pneumoperitoneum created in theuninsufflated peritoneal cavity, and within the inflated bag device 1,serves to extend the abdomen and provide additional working and viewingspace within the bag device 1.

FIG. 17 shows an organ being worked on in the inflated bag 1. In thiscase the organ is morcellated. The material is all retained safelywithin the bag and is not released into the cavity which could causemajor difficulties.

When the organ has been morcellated, the bag is readily removed throughthe original opening. All waste, blood, tissue and the like are safelyremoved and sealed within the bag 1.

FIG. 19 shows the bag device being inserted through a standard nakedincision. Once the specimen has been inserted into the bag 1 (FIG. 20)the ring 3 is pulled back out through the incision (FIG. 21) and atrocar 60 is inserted to create a gas seal (FIG. 22). It may also bepossible to insert the bag device 1 directly through a trocar.

In all cases there may be one or more access trocars used in addition tothe primary port. Thus, the invention includes procedures which involvetwo or more incision laparoscopy.

For example, FIGS. 23 and 24 show one arrangement in which an additionaltrocar 70 is inserted. In some cases, the additional trocar 70 may beextended through the bag whilst maintaining a seal.

A bag 1 is illustrated which has some depth which is preferred. However,a flat material can be used to form a holder in situ and the edges ofthe material pulled out through an incision and sealed outside, forexample by an access device 30.

The invention provides a method of inserting a large bag into theabdominal cavity to allow the insertion of a specimen into the bag. Thebag is then sealed and inflated and procedure carried out within thebag.

FIGS. 25 to 30 show various ways a bag 79 may be introduced into theabdomen.

In FIG. 25 the device may be inserted directly through an incision 80.

Referring to FIG. 26, the device may be inserted through a trocar 81.

In FIG. 27 a device may be inserted through a base retractor 82.

Referring to FIG. 28 a device may be inserted through a low profile port83.

As shown in FIG. 29 the device may be inserted through a Multi-portdevice 84. The multiport device may, for example, be of the typedescribed in U.S. Pat. No. 8,187,178 or US 20110071389A, the entirecontents of which are incorporated herein by reference.

Referring to FIG. 30 the device may be inserted through the base 85 of amulti-port device.

As illustrated in FIG. 31, once the bag 79 has been inserted thespecimen is placed inside.

FIG. 32 the lip of the bag 79 is pulled out through the opening.

FIG. 33 the bag 79 is sealed by re-inserting the trocar 60, replacingthe cap or inserting a morcallator 78. If necessary an extra seal may beapplied to the neck of the bag 79.

As shown in, FIG. 34, once the bag 79 is inflated additional trocars maybe inserted into the abdomen as normal and pierced through the bag 79.FIG. 34 also shows a morcallator 78 inserted through a trocar 60.

FIG. 35 shows the morcallator 78 being inserted without the need for atrocar. A sealing ring 77 may be applied around the shaft of themorcallator 78 if necessary to hold back gas.

Referring to FIGS. 36 to 45 a method of inserting a large bag 100 intoan abdominal cavity which may automatically open to allow the insertionof a specimen is illustrated. The bag 100 is foldable and has a topopening 105 which may be biased into the open configuration by retainingelements which in this case comprise semi-circular ring parts 101, 102which have attached tether elements 104, 103 respectively. A pouch 110is used to house the bag 100 in a folded/retracted configuration. Thepouch 110 has a grasping tab 111 and a pull string 115.

FIG. 36 illustrates the main components of the automatically opening bagdevice.

FIG. 37 illustrates a folded bag 100 inside the pouch 110. In FIG. 38the pouch 110 is inserted into the abdominal cavity with the aid of thegrasping tab 111. When the pouch is inside, the distal pull tether 104is pulled forward and the bag 100 is released. A rear pull string 115 ispulled in the opposite direction to aid release.

Referring to FIG. 40, it will be noted that as the distal end of the bag100 is pulled forward the rear of the bag 100 is pulled in the oppositedirection as it is attached to the pouch 110 with the connecting tether103. This action opens the mouth of the bag 100 sufficient to ease theinserting of specimens.

FIG. 41 shows specimens being placed on top of the bag opening 105.

Referring to FIG. 42, by pulling the distal pull tether 104 back andover the specimen, the bag 100 begins to unroll and the specimen travelsdeeper insider the bag 100. Referring to FIG. 43, as the front and backretaining elements 101, 102 of the bag opening are pulled outwards, thespecimen travels further into the bag 100.

FIG. 44 shows the rim of the bag being opened up and the incision beingcleared of excess bag material.

Referring to FIG. 45, the opening is re-sealed by attaching a cap, byinserting a trocar, or by inserting a morcallator through the opening.

Referring to FIGS. 46 to 54 there is illustrated another deviceaccording to the invention. The device is similar to that of FIGS. 36 to45 and like parts are assigned the same reference numerals. In this casea bag 120 is housed within a cartridge 121 for delivery andautomatically opens when it exits the cartridge 121 on insertion intothe abdominal cavity. In this case the ring part 102 remains attached tothe cartridge 121. A tether 125 extends between the distal end of thecartridge 121 and the ring element 102. The ring element 101 has atether element 126 which is grasped by an instrument 127 to pull the bag120 from the cartridge 121.

FIGS. 46 to 54 show the bag 120 housed in the cartridge 121 which can beinserted into a valve on an access port/trocar 130. The cartridge 121remains in place during the procedure.

Referring to FIG. 46, the loaded cartridge 121 is placed through a valveon the port 130. FIG. 47 shows the distal pull tether 126 that ispositioned so that it is easily grasped with an instrument 127. In FIG.48 an instrument 127 is inserted and the pull tether 126 is grasped.

Referring to FIG. 49, as the instrument/grasper 127 is pushed forwardthe bag 120 is released from the cartridge 121. As shown in FIG. 50,once the bag is in far enough, the tether 125 which connects the backside of the bag 120 to the cartridge 121 begins to open the bag 120 up.

Referring to FIG. 51, when the mouth of the bag 120 is sufficiently opena specimen may be placed inside. When the distal pull tether 126 ispulled back as illustrated in FIG. 52 this forces the bag 120 to unrolland the specimen to travel deeper into the bag 120.

Referring to FIG. 53, the cap/trocar 130 is then removed and the rim ofthe bag 120 is pulled out through the incision and mounted to theretractor 135. FIG. 54 shows the cap, trocar, or morcallatorreconnected. The bag 120 is then inflated.

Referring to FIGS. 55 to 63, there is illustrated a removable cartridge140 with a manually opened bag 141 for insertion through a single port142. These drawings illustrate a method of inserting a large bag 141which will be manually opened by the user when inserted into theabdominal cavity. FIGS. 55 to 63 show a bag 141 housed in a cartridge140 which plugs into a valve 142 on an access port/trocar 130. The bag141 is ejected from cartridge 140 using a plunger 145 and the cartridge140 is removed. As shown, for example, in FIG. 54, inflating the bagdevice 1 creates the artificial pneumoperitoneum and urges the bagagainst the abdominal wall. This arrangement allows one or moreadditional trocars 70 to extend through the abdominal wall and directlyand sealingly pierce the inflated bag device 1 where the bag device isurged against the abdominal wall. See, for example, FIGS. 24, 34, and35. Further facilitating this sealing of the additional trocars 70 tothe inflated bag device 1 is the fact that the inflated bag device 1 isapplying a retracting force to the materials outside the bag device andis thus secured in place against the abdominal wall.

Referring to FIG. 55, the bag 141 is loaded into a cartridge 140 whichis then inserted through a valve 142 on the port/trocar 130. When thecartridge 140 is in place of the plunger 145 is inserted through theproximal end of the cartridge 140 as illustrated in FIG. 56. Pushing theplunger 145 down as illustrated in FIG. 57 forces the bag 141 to ejectinto the abdominal cavity.

Referring to FIG. 58, when the bag 141 has been ejected, the cartridge140 may be removed, leaving an activation tether 147 in place. Aninstrument 148 is inserted as illustrated in FIG. 59 and the instrument148 is used to grasp the distal pull tether 149 which is attached to thefront band or ring part/element 101 on the bag 141.

Referring to FIG. 60, the specimen is then lifted into the open mouth ofthe bag 141. The surgeon can control the mouth of the bag 141 using theactivation tether 147. When both the front and the back ring elements101, 102 of the bag 141 are grasped as illustrated in FIG. 61, the bag141 can be pulled towards the incision, forcing the specimen to traveldeeper into the bag 141.

FIG. 62 shows the valve/trocar 130 being removed and the rim of the bagbeing pulled out through the incision. In FIG. 63, the rim of the bag141 is opened up, and the valve/trocar 130 are replaced to seal the bag141. The bag 141 is then inflated and the procedure carried out within.

Referring to FIGS. 64 to 74 there is illustrated a removable cartridge150 with a manually opened bag 151 (laparoscopic). These drawings show amethod of inserting a large bag 151 which can be manually opened by theuser when inserted into the abdominal cavity.

Referring to FIG. 64, the loaded cartridge 150 is inserted through apre-made incision. When the cartridge 150 is in place a plunger 152 isinserted as illustrated in FIG. 65. The plunger 152 is pushed all theway down and the bag 151 is ejected as shown in FIGS. 66 and 67.

Referring to FIG. 68 an instrument 155 is inserted through atrocar/access port 156 and is used to grasp a distal pull tether 157which is attached to the front band on the bag. Once the distal tether157 is held, pulling on the activation tether 158 opens the mouth of thebag 151 and forces the excess material to unroll. The specimen may nowbe lifted into the open mouth of the bag as shown in FIG. 69. Thesurgeon can control the mouth of the bag 151 to some degree with anactivation tether 158.

Referring to FIG. 70, with the back end of the bag 151 grasped, the bag151 can be pulled towards the incision, forcing the specimen to traveldeeper into the bag 151. The valve/trocar is removed and the rim of thebag is pulled out through the incision as illustrated in FIG. 71. Therim of the bag 151 is opened up, and the morcallator is inserted to sealthe bag as shown in FIG. 72. The bag is then inflated and the procedurecarried out within.

As illustrated in FIGS. 73 and 74, when the bag 151 is inflated trocars159 can be pierced through to allow access for additional instruments160.

Referring to FIGS. 75 to 87 there is illustrated the use of a bag 170 asdescribed above as a visceral retainer. The bag 170 is first insertedand positioned where required (FIG. 75). As the bag 170 is inflated,surrounding structures and organs (abdominal visecera) are retracted asshown in FIG. 76.

As shown in FIGS. 77 and 78, it may be of benefit to fill, or partiallyfill the bag 170 with a liquid. These benefits may include: 1) Thespecimen floats to the top of the bag and therefore the risk of bagdamage at the base may be reduced. 2) Liquid may reduce smoke build upin the bag. 3) Blood will be diluted and may therefore allow forenhanced visibility.

Referring to FIG. 79, when the bag 170 is in place and the neck has beenpulled through the incision there is often a lot of excess material inthe incision. A grommet 175 may be inserted through the bag/incision tokeep excess material away from the incision as illustrated in FIG. 80.This will help prevent damage to the bag 170 and aid visibility and gasflow. With the grommet 175 in place instruments can be inserted withease as shown in FIG. 81.

The grommet 175 may be used with multiport or single port access devices(FIG. 82).

In some cases the grommet 175 have an insufflation/desufflation line 176built in (FIG. 83).

As illustrated in FIG. 84 the grommet may include a series of slits 177which allow it to conform to various incision dimensions.

The grommet may include a valve system 178 as illustrated in FIG. 85.

An instrument locking mechanism 179 may also be included (FIG. 86).

In some cases, as illustrated in FIG. 87, the grommet may have a seriesof lumens 180 to aid with ventilation/insufflation.

Referring to FIGS. 88 and 89 there is illustrated a bag device 200according to the invention. In this case, the bag 200 is shown in theinflated configuration within a body cavity such as the abdomen. Atissue sample 201 is contained within the bag. An incision is made inthe abdomen 202 and the incision is retracted using a retractor 203 asdescribed above. In this case the retractor 203 has an outer proximalring 204 and a multilumen access port 205 is releasable mounted to thering 204. The bag 200 extends through the retracted incision andterminates in a retainer ring 206.

FIGS. 90 and 91 illustrate a bag device similar to that shown in FIGS.88 and 89 but in this case a single instrument lumen access port 211 ismountable to a proximal part of the refractor assembly. The access port211 may have a cannula section that extends through the refractor or maybe an access port 212 with a short proximal leg.

The bag device may itself have an access port to facilitate passage ofinstruments into and out of the bag and/or to facilitate passage of atissue sample into the bag.

Referring to FIG. 93 the bag has a single access port 220. However,there may be a plurality of such access ports as illustrated in FIG. 94.Passage of a tissue sample 225 through an access port 220 is illustratedin FIG. 95. The access port 220 may be provided with any suitable valvesuch as a choke valve, for example, for example a drawstring 226 asillustrated in FIG. 96, a cuff valve 227 as illustrated in FIG. 97, oran elastomeric valve 228 as illustrated in FIG. 98. The valve 228 may beof any suitable plastics, rubber or gel material.

Referring to FIGS. 99 to 110 there is illustrated various steps inmethods involving the use of the bag devices of the invention. In theexample illustrated the device is of the type described above. Themethods involve the use of a bag device 250, a retractor 251, anexternal access port system 252 and is used to access tissue 253 such asa specimen or an organ through an opening 254 in the body, in thisparticular case in the abdomen 255. The bag device has a deliveryconfiguration in which it is housed in a retracted condition in acartridge 260. A plunger 261 is used to deliver the retracted bag deviceout of the cartridge 260. The bag device 250 has an opening which isbiased into an open configuration by a retainer ring 265. The ring 265may be of a shape memory material as described above. A proximal tetherwhich in this case is in the form of a ring or loop 267 is provided onone side of the ring 265 and a distal tether 268 extends from the sideof the ring 265 generally opposite to the proximal tether 267.

In FIG. 99 the bag device is placed in the delivery configuration in thecartridge or pouch 260. In this case the access port device 252 is insitu on top of the retractor 251 and the cartridge 260 is insertedthrough one lumen of the access port (FIG. 100). The plunger 261 is usedto push the bag device 250 out of the cartridge 260 (FIG. 101). In thisparticular case the bag device is not tethered to the user, on delivery.On delivery into the body cavity, such as the abdomen, the retractorring is free to move to its normally expanded configuration in which itopens up the bag opening (FIG. 102). The bag is folded in the deliveryconfiguration. Using various instruments 270 a clinician manipulates atissue specimen, organ or the like and then delivers it into the bag 250through the open mouth of the bag (FIGS., 103, 104). FIGS. 105 and 106illustrate one particular way in which the bag containing the tissue isretrieved. A grasper type instrument 275 is led through the proximaltether loop 267 and is used to grasp the distal tether 268 (FIG. 105).The distal tether 268 is pulled through the proximal tether loop 267which ensures that the clinician has control over the bag as it is movedup towards the body opening (FIG. 106). As the retaining ring 265engages with the retractor 251 it retracts allowing it to be pulled upthrough the body opening (FIG. 107). The access port 252 is removed andthe retaining ring 265 is again free to expand (FIG. 108).

The access port 252 is re-attached and the bag is inflated to increasethe operative field. The tissue sample can then readily by worked on(FIGS. 109, 110) without the risk of any potentially harmful materialbeing released into the body cavity.

In some cases there may be a lock feature which prevents movement of onetether relative to the other in some directions. One such lock featureis illustrated in FIGS. 111 to 113. The distal tether has a one-way stepfeature 280 which permits the distal tether to pass through the proximalloop tether but once it has passed through this reverse movement isprevented as illustrated in FIG. 113. This ensures even greater controlon the movement of the retaining ring 265 to aid closing of the bag asthe ring 265 is being withdrawn.

As discussed above, the devices of the invention may be used in anysuitable body cavities. One such use is in the colon and one embodimentfor this use is illustrated in FIGS. 114 to 117. The device may beinserted as described above. Once in place and inflated a clinician caninspect the wall of the colon for any unusual features such as a growth.One such growth 280 is illustrated in FIG. 115. In this case, when agrowth 280 is identified some or all of the growth 280 may be accessedby cutting a hole in the wall of the bag which remains in place byvirtue of its engagement with the rest of the colon. Using variousinstruments, at least a portion of the growth 280 can be excised andremoved through the bag. As in the other embodiments described a majoradvantage is that the tissue to be removed is retained in the bag whichprevents potentially harmful material such as cancerous cells from beingreleased in the body cavity.

Referring to FIG. 118 there is illustrated another bag device 400 of theinvention. The bag device has a neck or collar region 401 between aretaining ring 402 and the main body of the bag. Because the retainingring 402 is of smaller diameter than that of the bag it is more easilyinserted through an access port. As shown in FIG. 118, the bag device400 includes joined planar sheet portions forming the neck region 401and a body portion 403. Also as shown in FIG. 118, the body portion 403forms a closed cavity in fluid communication with the neck region 401,and the body portion 403 has a length and width greater than a lengthand width of the neck region 401. As also shown in FIG. 118, theretaining ring 402 is configured to bias the bag opening toward an opencondition.

FIG. 119 illustrates another bag device 410 and shows how the main bodyof the bag may be folded in the retracted delivery configuration.

Referring to FIGS. 121 and 122, there is illustrated a bag 500 for usein laparoscopic surgery having an opening 502 to receive tissue and acuff or collar 503 extending around the opening 502. The bag 500 may beinflatable.

The bag 500 comprises a main body 505 which extends from the cuff 503.The main body 505 is more flexible than the cuff 503 to assist inretaining the bag 500 open in the deployed configuration. The cuff 503may be of a different material than that of the bag 500 or may comprisethe same or a similar material which is thicker than that of the mainbody 505 of the bag 500. In one case the cuff 503 is of a plasticsmaterial and the main body 505 of the bag 500 is of a plastics materialwhich is more flexible than that of the cuff 503. However, the cuff 503is sufficiently flexible to allow closing of the opening 502. A joint507 between the cuff 503 and the main body 505 of the bag may bereinforced in any suitable manner such as by using a double layer of thecuff material as illustrated in FIG. 3.

The cuff 503 has an axial extent which is important in maintaining theopening 502 in a fully open configuration. This has the major advantagethat tissue can be more readily manoeuvred into the opening 502 by thesurgeon performing a laparoscopic procedure through a small opening.When the bag 500 is in the open configuration the surgeon is able toconcentrate on manipulation of the tissue/material to be inserted intothe bag 500 without the added task of complex manipulation of the bag500 at the same time as the material is being manipulated. Thus, the bag500 greatly facilitates the laparoscopic surgical procedure.

The cuff 503 extends axially for a length which is sufficient to ensurethat the opening 502 remains open to provide an axially extendingdelivery mouth into the main body 505 of the bag 500. For example thecuff 503 may extend for an axial length of from 2 to 20 cm, 2 to 10 cm,or about 5 cm. Alternative size dimensions for the cuff or collar 503,as well as sizes for other features of the bag, will be discussed inmore detail below.

In the invention the cuff 5033 is biased into the open configuration. Inthis case the bag 500 comprises a biasing element to bias the cuff 503into the open configuration.

The biasing element may comprise a loop 510 extending around the cuff503. The loop may be of a shape memory material such as Nitinol. Theloop 510 extends round the cuff 503 in any suitable manner. It may, forexample, be threaded through the cuff as illustrated or may extendthrough a table or track provided in or on the cuff 503.

The cuff 503 has tabs 511, 512 which may be used for more readilygrasping the bag during a laparoscopic procedure.

A tether 515 extends from the cuff 503 and may be used to activate theopening and/or closing of the bag 500.

Referring to FIG. 120, the bag 500 is folded and housed in an introducersheath or pouch 520 ready for deployment. Any suitable insertion toolmay be used to deliver the bag 500 through an opening. The bag 500 maybe deployed in any suitable manner such as by using a plunger 516 whicha user activates to deliver the bag from the introducer 520.

The deployment of the bag 500 through an opening such as a retractedincision 525 is illustrated in FIGS. 123 to 126. As soon as the bagstarts to exit the pouch the cuff 503 opens up and when fully deployeddefines an axially extending open mouth. FIGS. 127 and 128 illustratetissue 530 being manipulated into the open mouth of the bag 500 using aninstrument such as a grasper 531. When the tissue 530 is in the bag 500the tether 515 is used to pull the cuff 503 which initially closes theopening and is then pulled out through the tissue opening 525. When theproximal end of the bag 500 has passed through the tissue opening thebag 500 may be inflated and a procedure carried out on the tissueisolated within the bag 500. This may be carried out in severaldifferent ways, depending on the procedure being performed. For example,the bag entrance may be closed with an access port 540 as illustrated inFIG. 133 which facilitates access of any suitable instruments to performprocedures such as morcellation of the tissue within the bag 500.Alternatively access is gained to the captured tissue without arequirement for an access port—see FIGS. 134, 135 and 138. Alternativelya trocar 545 may be provided through which an instrument is passed (FIG.136). There may be additional trocars 550 used (see FIG. 137, forexample).

The collar/cuff 503 may be collapsible to allow tissue to be rolled intothe bag opening 502 rather than being lifted into the bag opening 502.

The bag 500 may be mounted to a retractor. One such retractor comprisesa distal anchoring ring, a retractor member such as a sleeve, and aproximal ring assembly. One such retractor is described in US2005-0090717 A, the entire contents of which are incorporated herein byreference. The distal anchoring ring is located within a wound interior,in use. In this case the distal anchoring ring is provided in the formof an O-ring. The proximal ring assembly is located externally of awound opening, in use. The retractor member may be employed to retractlaterally the sides of a wound opening. In one case the retractor memberis provided in the form of a sleeve.

The proximal end of the retractor is closable by a cap which maycomprise an instrument access device 540 which may have a number ofinstrument ports to effect a seal around an instrument extended throughthe device. The instrument access device may be releasably mountable toa proximal ring assembly of a retractor. At least some of the instrumentports may include a stalk which is laterally flexible and longitudinallyrigid. One such instrument access port is described in U.S. Pat.No.8,187,178 or US2011-0071389A, the entire contents of which areincorporated herein by reference.

FIG. 127 shows an organ or tissue such as an uterus which has beensevered/amputated from it's retaining structures.

FIGS. 123 to 126 illustrate the bag device being inserted into theabdominal cavity at the beginning of a procedure or as and whenrequired. The bag is inserted in a small flattened state for ease ofinsertion through a small opening such as an incision. The bag may alsobe introduced through a valve without the need to remove an access cap.

When the bag is inserted it is opened up. An organ 530 is then readilymanipulated for insertion into the bag as illustrated in FIG. 128. Therelative rigidity of the cuff 503 keeps the bag open to facilitateinsertion of an organ.

FIG. 129 shows the organ located in the bag and the cuff 503 beinggrasped to facilitate manipulation of the bag towards the opening. Thecuff 503 is pulled out through the opening. The bag may be mounted to aproximal ring assembly of a retractor and a cap may be mounted to theproximal assembly. FIG. 131 illustrates the device in place with anorgan enclosed within the bag.

The bag is then inflated (FIG. 132) through an insufflation port. Theinflation of the bag has the additional benefit of applying a retractingforce to the materials outside the bag thereby creating additionalspace.

FIG. 133 shows an organ being worked on in the inflated bag. The organmay be morcellated. The material is all retained safely within the bagand is not released into the cavity which could cause majordifficulties. The bag is retained externally, for example byclamping/connecting to a retractor.

When the organ has been morcellated the bag is readily removed throughthe original opening. All waste, blood, tissue and the like are safelyremoved and sealed within the bag.

The bag device may be inserted through a standard naked incision. Oncethe specimen has been inserted into the bag an opening such as a cuff503 is pulled back out through the incision and a trocar may be insertedto create a gas seal. The bag device may also be inserted directlythrough a trocar as illustrated in FIG. 136.

In some cases there may be one or more access trocars used in additionto the primary port. Thus, the invention includes procedures whichinvolve two or more incision laparoscopy.

For example, FIG. 137 shows one arrangement in which an additionaltrocar is inserted. In some cases, the additional trocar may be extendedthrough the bag whilst maintaining a seal.

The invention provides a method of inserting a large bag into theabdominal cavity to allow the insertion of a specimen into the bag. Thebag is then sealed and inflated and procedure carried out within thebag.

As discussed above, the devices of the invention may be used in anysuitable body cavities. One such use is in the colon. The device may beinserted as described above. Once in place and inflated a clinician caninspect the wall of the colon for any unusual features such as a growth.In this case, when a growth is identified some or all of the growth maybe accessed by cutting a hole in the wall of the bag which remains inplace by virtue of its engagement with the rest of the colon. Usingvarious instruments, at least a portion of the growth can be excised andremoved through the bag. As in the other embodiments described a majoradvantage is that the tissue to be removed is retained in the bag whichprevents potentially harmful material such as cancerous cells from beingreleased in the body cavity.

Referring to FIGS. 139 to 155 various embodiments of biasing loopelements which may be used in the bag device of the invention to assistin maintaining the bag open are illustrated. In these cases the loopcomprises a number of loop parts which are movable relative to oneanother for loading deployment, and/or retrieval.

Referring to FIGS. 139 to 143 in this case there are two joined loopparts 551 a, 551 b which are movable circumferentially through hoops552. In some cases a single piece loop is sufficiently flexible to allowmanipulation.

Referring to FIGS. 144 and 149 in this case a loop 560 is configured inthe manner of a noose with a leg 561 extending from the loop which maybe pulled to reduce the diameter of the loop. There is a closed loop 562on one end and a kink 563 on the other end which links into the loop 562to facilitate reducing the diameter of the loop 560.

Referring to FIGS. 150 to 153 in this case there may be closed loops570, 571 at each end of the retaining loop 572. These may be used astether attachment points.

Referring to FIGS. 154 to 156 in this case the ends of a retaining loop580 have bends 581, 582 and extend to define arms 583, 584 whichfacilitate manipulation of the loop for retrieval.

The device of the invention may include features to isolate the contentsof the bag from the wound opening and hence protect from escape ofmaterial as could occur with seeding of cancer cells and the like.

Referring to FIGS. 157 to 160 in this case the bag comprises a smallopening 600 which remains closed under insufflation pressure. Theopening 600 is opened on insertion of an implement such as a trocar 601through the opening 600. The bag has excess material in the region ofthe opening 600 which defines a sleeve or chimney 603 which seals alongpart of the length of the trocar shaft when the shaft is in place in theopening 600. The opening 600 is located at the top of the bag, in usei.e. in the region that touches the abdominal wall. A trocar 601 may beinserted in a region of the abdominal wall remote from key organs andmanipulated under full vision to locate the opening. The opening staysclosed whilst there is internal insufflation pressure and the sleeve orchimney 603 collapses around the trocar to create a seal.

Referring to FIGS. 161 to 163, in this case any excess bag material 604may be grasped using a grasper 605 inserted through a trocar 606. Theend of the excess material may then be cut (FIG. 162) creating a chimney607 extending from the bag. The chimney 607 is then sealed—for exampleusing a threaded trocar 608 which is twisted inside the chimney 607 tocreate a seal. The chimney 607 prevents contact between the wound anddebris created during morcellation. In this case the surgeon is providedwith an additional port into the bag for use during the procedure. Onesuch procedure may involve insertion of a laparascope or a grasper, forexample through the secondary port.

Referring to FIG. 164, in another embodiment a bung 610 may be placedinside the trocar 606, sealing the bag to the trocar. An implement suchas a laparascope 611 may be inserted through the bung 610.

Referring now to FIG. 165, in this case the bag has a cuff 620 and atether 621 loop is threaded through the cuff. The tether 621 has a strap622 which may be used to pull on the tether from a location external ofthe abdomen. The cuff 620 also has grasping tabs 623, 624. In this casea grasper 625 may be used to grip the tab 623 as illustrated and thenpush the cuff towards the opposite side of the bag, towards the tab 624,thus closing the bag. The strap 622 enables the bag to be held firmlywhilst being closed within the pneumoperitoneum.

In some cases the bag is retained in the normally open configuration bya retainer ring of a shape memory material such as Nitinol. It has beenfound that a single ring formed by attaching, for example by welding,together the ends of a ring-forming member is most efficient inachieving rapid deployment. Referring to FIGS. 185 and 186 the retainingring of the bag may be manufactured in any suitable manner. In one case,for example, a shape memory material 675 is formed into a loop, shapeset and welded. A tether strap 676 may also be attached in any suitablemanner.

In some cases the cuff of the bag may have features to facilitatemounting of the pre-formed ring to the bag.

In one embodiment illustrated in FIG. 166 the bag has a cuff 630 throughw hich a loop 631 of a shape memory material such as Nitinol is led.Internal capturing regions 632 for the retaining loop 631 are created bycutting panels in the material of the bag and folding down over theretaining loop 631 and sealing using a suitable tool such as a circularsealing tool. A tether strap 632 is mounted to the loop 631 and extendsthrough an access port 633 to maintain control over the bag.

Referring to FIG. 167, in this case pressed out attachments 635 arefolded over a closed retaining loop 636 of a shape memory material suchas Nitinol and sealed, for example by heating. A front grasping tab 637includes reinforced attachment loops 638.

FIGS. 168 to 170 illustrate another method of attaching a retaining loop640 to a cuff 641 of a bag according to the invention. In this case thematerial of the collar or cuff 641 is punched out with a cut detail 642extending from a hole 643 (through which the retaining ring 640 isextended) to the edge of the cuff. The cuff is formed into a collar 641as illustrated in FIGS. 169( a) to 169(c). The retaining ring 640 isinserted through the cut details 642 and into the receiving holes 643.Using a circular sealing tool, the tabs are folded down to create analternating overlap. The cuff is then sealed, for example by heatsealing to close the holes 643. In this way a closed loop 640 of a shapememory material such as Nitinol is attached to the bag to maximise theopening and facilitate insertion of tissue laparascopically when the bagis within the abdomen.

In some embodiments the abdominal bag is protected from damage duringuse of a morcellator. For example, as illustrated in FIG. 171 aninsert/cannula 650 may be inserted to isolate a morcellator from thematerial of the bag. The insert 650 may for example be rigid, flexibleor of a segmented rigid material. An access port or cap 651 may bereleasably mountable to the insert 650.

The device used to introduce the bag into an insufflated abdomen may beadapted to control the opening of the bag. For example, as illustratedin FIGS. 172 to 176 a tip 655 of an introducer sheath 656 may havemirrored slots 657 which allow a retaining ring of the bag to start toexpand before the full bag is inserted. Such an introducer will aidmaneuvering of the bag into a desired position before the bag becomesdetached from the introducer. In addition, the deployed bag can bepartially withdrawn into the introducer to enable further rigid movementof the bag to optimise positioning.

To limit blood or other material being pushed into the introducer by thepositive insufflation pressure within the abdomen the tip of theintroducer may have pressure dissipating features. For example, asillustrated in FIGS. 177 to 180 the introducer tip may have variousslots 660, holes 661 and/or tapering features 662.

In another embodiment as illustrated in FIG. 189 to restrict blood orother material from entering the introducer, a shaft 695 of theintroducer may have a valve 696 at the proximal end. The valve 696 maybe openable on insertion of a pusher 697 used to deploy the bag devicefrom the introducer.

It will be appreciated that the bag of the invention may comprisedifferent materials to fulfil different requirements for sections of thebag. For example, as illustrated in FIGS. 181 and 182 a main body 665 ofthe bag may be made from a relatively thin flexible material and acollar 666 of a thicker, more rigid material. For example, the main body665 may include a sterilized polyester polyurethane, such as SS-1495-95(95 shore A polyester polyurethane blown film with high slop surface andgood clarity), and the collar or neck portion 666 may includes asterilized polyether polyurethane, such as ST-625-85 (85 Shore Apolyether polyurethane formulated for medium/high slip with goodsealability).

The bag may also be of any desired shape/profile. For example, the bagmay be of oval or elliptical profile as illustrated in FIGS. 181 to 184.This shape assists in pushing organs such as a section of bowel awayfrom the abdominal wall which prevents the bowel from migrating over thetop of the bag. As shown in FIG. 184, the creation of the artificialpneumoperitoneum includes positioning the joined edges 671 of the bag inalignment with the lateral walls of the abdomen 672 such that one of theplanar sheet portions of the bag faces, and is in contact with, theanterior abdominal wall, and the other sheet portion of the bag facesand contacts the visecera. Tissue 670 is illustrated in FIGS. 183 and184 within the bag.

The bag may be sized to be larger than the peritoneal cavity of thepatient so as to provide apposition against the abdominal wall afterinflation. The oversized nature of the bag, and the loading of the baginto the introducer as described below in connection with FIGS. 187( a)to 187(f), allows any additional bag material after inflation to remainrolled at the bottom of the bag. This helps to minimize pleats or foldsof the inflated bag from extending into the artificial pneumoperitoneum.Consistent with this, and as shown in FIG. 181, the bag may be sized toinclude a total bag length 661 of between 300 and 600 mm, or between 400and 550 mm, or approximately 500 mm, all in an uninflated condition. Thebag may also include a maximum width 677, for example in the bodyportion 665, of between 200 and 500 mm, or between 300 and 400 mm, orapproximately 350 mm, all in the uninflated condition. The collar orneck 666 may include a constant width 663 of between 150 and 350 mm, orbetween 180 and 320 mm, or approximately 250 mm, all in a bag uninflatedcondition and when the neck 666 is flattened as shown in FIG. 181. Thecollar or neck 666 may also include a length 664 of between 100 and 300mm, or between 100 and 200 mm, or approximately 150 mm, in a baguninflated condition. The main body 665 may include a main body length667 (not including the neck) of between 200 and 500 mm, or between 300and 400 mm, or approximately 350 mm. Also, main body 665 may beconfigured to have a maximum width to maximum length ratio ofapproximately 1:1.

Also, as noted above, the bag may be retained in the normally openconfiguration by a retainer ring of a shape memory material such asNitinol. Referring to FIGS. 166-170, the retaining ring of the bag maybe formed into a loop, shape set and welded. The diameter of the bagopening when the retaining ring is in an open configuration may bebetween 100 and 220 mm, or between 120 and 200 mm, or approximately 160mm.

Referring again to FIGS. 181 and 182 the bag may be formed from shapedflat sheet laid on top of one another and attached at the edges 671, forexample by welding. When inflated (FIG. 182), the bag expands into anovoid type shape with rounder corners which can more closely align withthe contours of the abdomen. Also as shown in FIGS. 118, 181, and 182,the bag may be shaped to be symmetric about two different planes (668,669) that are normal to one another. In addition, as shown in FIGS. 118and 181, neck or collar portion (401, 666) may be shaped to extendparallel to a longitudinal axis 273 of the bag, and thus edges 674 ofthe neck or collar portion (401, 666) may extend parallel to thelongitudinal axis 273 of the bag.

The bag of the invention in some cases may be manipulated to optimiseease of loading into an introducer and/or to optimise deployment. Forexample, as illustrated in FIGS. 187( a) to 187(f) the bag may be widerat certain sections 680. These extra width sections may be foldedinwardly from the side to form pleats 681. The bag may then be rolledfrom the bottom up towards the neck 682 of the bag. The neck 682 of thebag may then be scrunched down and loaded into an introducer 683.

Referring to FIG. 188 in some cases sections of the bag may be of adifferent material and or material thickness in order to provide desiredproperties. For example, a bottom section 690 of the bag may be of astranger/more rigid material to resist the action of a morcellator. Thesection 690 may be of a rip-stop nylon material, by way of example.

FIGS. 190( a) to 190(c) illustrate the use of the bag device of theinvention in transvaginal procedures, for example hysterectomies. Insome cases (FIGS. 190( a) and 190(b)) the bag device may be inserted andused directly without an access port. In other cases, the device may beused as described in other embodiments with an access port 730 (FIG.190( c)).

Referring to FIG. 191, in some cases the twisting action of a threadedtrocar or bung 700 may assist in putting the bag up through the wound.

In some embodiments, in order to seal the hole into the chimney beforethe bag is deflated a closure device or valve may be deployed. Forexample, as illustrated in FIGS. 192( a) and 192(b) a closure device 710may be inserted into the chimneys in a collapsed configuration anddeployed at the distal end of the chimney. The closure device may beretained in place using any suitable retaining means such as an adhesivepad(s) 711.

The abdominal bag device of the invention may be used with any suitableaccess port system 730 as illustrated, for example, in FIGS. 193( a) to193(c). In some cases the access port is mounted within the neck of thebag.

Various features of the invention are described and illustrated. It willbe appreciated that at least some of the features described in relationto one embodiment may be used not only in the embodiment specificallydescribed but also in other appropriate embodiments. As used herein, theterm “approximately” or “about” is understood to mean close in value oramount, but not precise. To the extent that such a definition for“approximate” or “about” is not considered sufficiently definite,approximate is understood to mean plus or minus 5% of the relevantparameter.

The invention is not limited to the embodiments hereinbefore described,with reference to the accompanying drawings, which may be varied inconstruction and detail.

The invention claimed is:
 1. An inflatable artificial pneumoperitoneumbag, comprising: a length and a width; an artificial pneumoperitoneumbag neck portion having a first end and a second end, the first endforming a bag opening; an artificial pneumoperitoneum bag body portionforming a closed cavity in fluid communication with the second end ofthe neck portion, the body portion having a length and width greaterthan a length and width of the neck portion; and a ring located at thebag opening, the ring configured to bias the bag opening toward an opencondition; wherein the length of the bag is between 300 and 600 mm, amaximum width of the bag is between 200 and 500 mm, and the neck portionhas a length of between 100 and 300 mm all when the bag is uninflated,and wherein the neck portion has a diameter of between 100 and 220 mmwhen in the open condition; and wherein the bag includes sterilizedpolyurethane planar sheet portions haying joined edges.
 2. Theinflatable artificial pneumoperitoneum bag of claim 1, wherein awidth-extending cross-section of the body portion includes an oval shapewhen the bag is inflated.
 3. The inflatable artificial pneumoperitoneumbag of claim 1, wherein the bag is symmetric about two planes that arenormal to one another.
 4. The inflatable artificial pneumoperitoneum bagof claim 1, wherein the neck portion includes edges that extend parallelto a lengthwise axis of the bag.
 5. The inflatable artificialpneumoperitoneum bag of claim 1, wherein the ring is formed of a shapememory material and is received through loops in the neck portion. 6.The inflatable artificial pneumoperitoneum bag of claim 1, wherein theplanar sheet portions are flat sheets laid on top of one another.
 7. Aninflatable artificial pneumoperitoneum bag, comprising: a first planarsheet portion and a second planar sheet portion, the first and secondplanar sheet portions having joined edges to form the pneumpoeritoneumbag having a length and a width; a neck portion having a first end and asecond end, the first end forming a bag opening; a body portion forminga closed cavity in fluid communication with the second end of the neckportion, the body portion having a length and width greater than alength and width of the neck portion; and a ring located at the bagopening, the ring configured to bias the bag opening toward an opencondition; wherein the length of the bag is between 300 and 600 mm, amaximum width of the bag is between 200 and 500 mm, and the neck portionhas a length of between 100 and 300 mm all when the bag is uninflated,and wherein the neck portion has a diameter of between 100 and 220 mmwhen in the open condition.
 8. The inflatable artificialpneumoperitoneum bag of claim 7, wherein the bag includes sterilizedpolyester polyurethane.
 9. The inflatable artificial pneumoperitoneumbag of claim 7, wherein the ring is formed of a shape memory materialand is received through loops in the neck portion.
 10. The inflatableartificial pneumoperitoneum bag of claim 7, wherein the planar sheetportions are flat sheets laid on top of one another.
 11. An inflatableartificial pneumoperitoneum bag, comprising: a first planar sheetportion and a second planar sheet portion, the first and second planarsheet portions having joined edges to form the pneumpoeritoneum baghaving a length and a width; a neck portion having a first end and asecond end, the first end forming a bag opening; a body portion forminga closed cavity in fluid communication with the second end of the neckportion, the body portion having a length and width greater than alength and width of the neck portion; and a ring located at the bagopening, the ring configured to bias the bag opening toward an opencondition; wherein the length of the bag is between 300 and 600 mm, amaximum width of the bag is between 200 and 500 mm, and the neck portionhas a length of between 100 and 300 mm all when the bag is uninflated,and wherein the neck portion has a diameter of between 100 and 220 mmwhen in the open condition; wherein a width-extending cross-section ofthe body portion includes an oval shape when the bag is inflated.
 12. Aninflatable artificial pneumoperitoneum bag, comprising: a first planarsheet portion and a second planar sheet portion, the first and secondplanar sheet portions having joined edges to form the pneumpoeritoneumbag having a length and a width; a neck portion having a first end and asecond end, the first end forming a bag opening; a body portion forminga closed cavity in fluid communication with the second end of the neckportion, the body portion having a length and width greater than alength and width of the neck portion; and a ring located at the bagopening, the ring configured to bias the bag opening toward an opencondition; wherein the length of the bag is between 300 and 600 mm, amaximum width of the bag is between 200 and 500 mm, and the neck portionhas a length of between 100 and 300 mm all when the bag is uninflated,and wherein the neck portion has a diameter of between 100 and 220 mmwhen in the open condition; wherein the bag is symmetric about twoplanes that are normal to one another.
 13. An inflatable artificialpneumoperitoneum bag, comprising: a first planar sheet portion and asecond planar sheet portion, the first and second planar sheet portionshaving joined edges to form the pneumpoeritoneum bag having a length anda width; a neck portion having a first end and a second end, the firstend forming a bag opening; a body portion forming a closed cavity influid communication with the second end of the neck portion, the bodyportion having a length and width greater than a length and width of theneck portion; and a ring located at the bag opening, the ring configuredto bias the bag opening toward an open condition; wherein the length ofthe bag is between 300 and 600 mm, a maximum width of the bag is between200 and 500 mm, and the neck portion has a length of between 100 and 300mm all when the bag is uninflated, and wherein the neck portion has adiameter of between 100 and 220 mm when in the open condition; whereinthe neck portion includes edges that extend parallel to a lengthwiseaxis of the bag.